FORMULATION OF COATED BUTYRATE TABLETS

COMBINED SYNOPSIS / SOLICITATION WORKFORM Action Code: Combined Synopsis/Solicitation Date: May 19 Year: 2020 Contracting Office Zip Code: 20892 Classification Code: Q031 Contracting Office Address: 6710 B Rockledge Drive Bethesda, MD 20892 Subject/Title: Formulation of Coated Butyrate Tablets Proposed Solicitation Number: NICHD-20-106 Closing Response Date: June 4, 2020 Contact Point: Verne Griffin Contract Award and Solicitation Number: TBD Contract Award Dollar Amount: TBD Contract Line Item Number(s): See 1449 Contractor Award Date: TBD Contractor Name: TBD Description: The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is conducting a market survey to determine the availability and technical capability of qualified small business, veteran-owned small business, service-disabled veteran-owned small business or HUBZone small businesses capable of providing Formulation of Coated Butyrate Tablets for Investigational New Drug submission to FDA. The Obesity and Diabetes Clinical Research Section (ODCRS) conducts studies of factors that affect energy balance including interventions that might affect energy intake and thus promote weight loss. We have designed a study to test whether oral butyrate when absorbed in the large intestine will affect energy intake. To facilitate absorption in the large intestine the butyrate tablets need to be coated to resist degradation in the acidic gastric environment. This requires an investigational new drug (IND) application to the FDA. The FDA is requesting specific data on quantitative composition of the sodium, a certificate of analysis for the drug product lot to be used in the clinical study which needs to include the identity, assay, purity, and microbiologic attributes for the drug product. They are also requesting a summary of the manufacturing process and stability data and a commitment to continue to support stability data for the duration of the clinical trial. Kydes pharmaceutical is able to provide all these requirements. This study is in direct support of the primary mission of ODCRS and NIDDK. Responses to this notice shall contain enough information to establish the interested parties bona-fide capabilities for fulfilling the requirement. "This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.” The solicitation number is NICHD-20-106 and the solicitation is issued as a request for quote (RFQ). The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-06 effective 20 May 2020. The associated NAICS code is 541380, Testing Laboratories, and the small business size standard is $15. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13. The Contractor Requirements are listed below: Scope ODCRS has written a protocol to test whether administration of oral butyrate will decrease food intake. This is a double-blind randomized placebo-controlled trial. For this study, we will require coated butyrate tablets and matching placebo pills. The butyrate and matching placebo will need to be coated with Eudragit S100 to allow passage into the large intestine for absorption. The protocol is powered for 24 participants who will take 11 days of oral butyrate and 11 days of placebo (in random order). Participants will be administered 2 grams of butyrate or matching placebo daily using 500mg coated tablets. Thus, we will need 1,056 butyrate and 1056 placebo tablets for these 24 participants. However, to allow for study withdrawals, losses and yield during compression and coating and samples needed stability testing during the study a larger number of tablets (10,000 butyrate and 10,000 placebo) will be needed. The Contractor shall perform the following tasks: 1. The vendor shall create a process document which is a step by step development plan for process of encapsulation and coating parameters, testing and data to be recorded. The vendor shall then implement an analytical method for sodium butyrate applying published method validations. This will involve the vendor purchasing 10 kg of pharma grade Sodium Butyrate from Sigma-Aldrich. The vendor shall determine the potency and purity of the sodium butyrate using USP reference standards and submit samples for microbiological testing. The sodium butyrate would then be blended with 2% citric acid and the other excipients and tablets will be compressed to contain equivalent of 500mg Sodium butyrate NF. The tablets will be coated with Eudragit and selected at 5,7.5,10 and 15% target weight. Dissolution of enteric coated sodium butyrate will be conducted, and tablet weight gain will be selected for clinical material manufacture. 2. Manufacture of clinical material: Vendor shall write and will get review and approval for production batch record for active and placebo tablets. Then sodium butyrate will be blended (5kg batch) with 2% citric acid. Assay and blend uniformity analysis will be performed. Then vendor shall manufacture 10,000 tablets containing 500mg sodium butyrate. Assay and dosage uniformity will be performed for compressed tablets. Vendor shall compress 10,000 placebo tablets containing starch 1500/microcrystalline cellulose. The vendor shall enteric coat the tablets with Eudragit S100 with triethyl citrate as plasticizer. The coating thickness will be estimated from the increase in weight after coating and will be expressed as the target weight. The vendor will conduct dissolution testing (on at least n=6 tablets) in 0.1N HCL for 2 hours followed by pH 7.2 for 2 hours. The vendor will establish acceptance criteria of no more than 10% release in 0.1N HCL and no less than 80% release at pH 7.2. The vendor shall alternatively use USP acceptance criteria for delayed dosage release. The vendor shall then issue a certificate of analysis and write and get approval for the stability testing protocol and initiate concurrent stability testing. 3. QA/Regulatory support: The vendor shall review and approve Master Batch Records, issue Product Batch records, assist with manufacturing (area clearance), review analytical data, review Product Batch records and review and issue certificate of analysis. 4. Ongoing stability testing: the vendor will provide stability testing for up to 36 months under conditions of 25°C/60% RH at 1,3,6,12,18,24 and 36 months) and 40°C/75% RH at 1,3, and 6 months. The tests will include appearance, potency and dissolution testing. Period of Performance: Base Year: June 5, 2020 -1/01/2021 Option 1*: 01/02/2021 – 01/01/2022 Option 2*: 01/02/2022 - 01/01/2023 (viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. (ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable. Award will be made to the contractor providing the most advantageous quote to the Government. Technical factors, , and price considered. Technical Factors: 1. Technical Acceptability: Proposal. The Government will evaluate the Offeror’s ability to provide the services that comply with the technical requirements of the SOW to be deemed technically acceptable, the Offeror’s proposal must demonstrates the Offeror’s ability to successfully execute the requirements in the SOW based on qualifications, education levels, knowledge and experience. 2. Technical Approach. Comprehension of the work, including creativity and thoroughness shown in planned execution of the project; Use of methods and techniques for completing each task, cost savings and feasibility of approach, identification of challenges and solutions, relevant task within the past three years. (x) FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision. (xi) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. Including the following clauses and Prohibitions: 52.219-28, Post Award Small Business Program Representation 52.222-3, Convict Labor 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Equal Opportunity for Workers with Disabilities 52.222-50 Combating Trafficking in Persons 52.225-13, Restrictions on Certain Foreign Purchases 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving Additional Clauses: 52.217-9, Option to Extend Services (xiii) Additional Contract Requirements: None (xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable. (xv) Offers shall be submitted via the Fed Connect web portal (www.fedconnect.net). The due date for receipt of offers is 1100 AM Eastern Time on June 4, 2020 Place of Contract Performance: National Institute of Health, NIDDK DIR/PECRB/ODCRS 4212 North 16th Street Phoenix, AZ 85016 Set-aside Status: None